~7 spots leftby Dec 2026

CD30 CAR T-Cells for Testicular Cancer

Recruiting in Palo Alto (17 mi)
Matthew I. Milowsky - UNC Lineberger
Overseen byMatthew Milowsky, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: UNC Lineberger Comprehensive Cancer Center
Disqualifiers: Pregnancy, HIV, Hepatitis B, others
No Placebo Group
Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment to fight certain types of cancer in adults. The treatment aims to improve how the body targets and kills cancer cells. Researchers will collect samples to see how well the treatment works and lasts in the body.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that CD30 CAR T-Cells for Testicular Cancer is an effective treatment?

The available research shows that CD30 CAR T-Cells have demonstrated antitumor activity against embryonal carcinomas, a type of testicular cancer, in both laboratory and animal studies. These cells were able to target and kill cancer cells that express the CD30 marker, as well as nearby cancer cells that do not express this marker, through a special interaction. This suggests that CD30 CAR T-Cells could be a promising treatment for testicular cancer, especially for aggressive types that are difficult to treat with standard therapies.12345

What safety data is available for CD30 CAR T-Cell therapy in testicular cancer?

The safety data for CD30 CAR T-Cell therapy, while not specific to testicular cancer, can be inferred from general CAR T-Cell studies. CAR T-Cell therapies, including those targeting CD30, have shown potential in treating hematologic malignancies with some success. However, they are associated with risks such as cytokine release syndrome, neurotoxicity, and 'on-target off-tumor' effects, where healthy cells expressing the target antigen may also be affected. Strategies to mitigate these risks, such as pharmacologic interventions and suicide genes, are under investigation. CD30 CAR T-Cells have been noted to spare CD30+ hematopoietic stem cells while targeting lymphoma cells, suggesting a level of safety in targeting CD30. Overall, while promising, CAR T-Cell therapies require careful management of potential toxicities.678910

Is the treatment ATLCAR.CD30 Cells a promising treatment for testicular cancer?

Yes, ATLCAR.CD30 Cells, which are a type of CAR T-cell therapy, show promise for treating testicular cancer. They can target and kill cancer cells that have the CD30 marker, and they can also attack nearby cancer cells that don't have this marker. This makes them a strong candidate for treating aggressive forms of testicular cancer.1451112

Research Team

Matthew I. Milowsky - UNC Lineberger

Matthew Milowsky, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

Adults over 18 with Nonseminomatous Germ Cell Tumors (NSGCT) who've had at least one prior treatment can join. They must show tumor growth or elevated cancer markers after high-dose chemo. Pregnant women, those breastfeeding, and individuals with active HIV, HTLV, hepatitis B or C are excluded.

Inclusion Criteria

I am 18 years old or older.
My cancer is a type of germ cell tumor that is not seminoma.
I have had at least one treatment for my non-seminoma germ cell tumor.
See 2 more

Exclusion Criteria

I do not have active HIV, HTLV, hepatitis B, or hepatitis C infections.
Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated in the study).

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Administration of autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) to subjects with CD30+ Nonseminomatous Germ Cell Tumors

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of overall response rate and progression-free survival

12 weeks

Long-term Follow-up

Monitoring of overall survival and persistence of ATLCAR.CD30 in peripheral blood

Up to 5 years

Treatment Details

Interventions

  • ATLCAR.CD30 Cells (CAR T-cell Therapy)
  • Cyclophosphamid (Alkylating agents)
  • Fludarabine (Anti-metabolites)
Trial OverviewThe trial is testing ATLCAR.CD30 Cells combined with Cyclophosphamide and Fludarabine in patients with NSGCT. It's a phase 2 study to see if modified T cells from the patient's blood can fight cancer more effectively when combined with antibodies.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ATLCAR.CD30Experimental Treatment3 Interventions
Single Group Assignment: Subjects with Nonseminomatous Germ Cell Tumors who meet eligibility criteria for cellular therapy.

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+
Dr. Shelley Earp profile image

Dr. Shelley Earp

UNC Lineberger Comprehensive Cancer Center

Chief Medical Officer since 2018

MD from Johns Hopkins Medical School

Dr. Robert L. Ferris profile image

Dr. Robert L. Ferris

UNC Lineberger Comprehensive Cancer Center

Chief Executive Officer

PhD in Immunology and MD from Johns Hopkins Medical School; Bachelor's in Chemistry from UNC-Chapel Hill

University Cancer Research Fund at Lineberger Comprehensive Cancer Center

Collaborator

Trials
5
Recruited
150+

Findings from Research

The study demonstrates that CD30-targeted CAR-T cell therapy is effective in treating recurrent and malignant CD30-positive peripheral T-cell lymphomas (PTCL), showing significant tumor suppression in both laboratory and mouse model experiments.
The engineered 9C11-2 CAR T cells exhibited strong cytotoxic effects against CD30-positive cancer cells, indicating their potential as a promising therapeutic option for patients with this type of lymphoma.
A new immunotherapy strategy targeted CD30 in peripheral T-cell lymphomas: CAR-modified T-cell therapy based on CD30 mAb.Wu, Y., Chen, D., Lu, Y., et al.[2022]
In a study of 72 patients with extranodal natural killer/T-cell lymphoma (NKTCL), 56% of cases were found to express CD30, which was associated with better responses to non-anthracycline-based therapies.
CD30 positivity, particularly at a cutoff value of 5%, was linked to longer overall survival in patients treated with non-anthracycline chemotherapy, suggesting that CD30 could serve as a valuable prognostic factor and therapeutic target in NKTCL.
Prognostic implications of CD30 expression in extranodal natural killer/T-cell lymphoma according to treatment modalities.Kim, WY., Nam, SJ., Kim, S., et al.[2022]
Brentuximab vedotin, a targeted therapy that effectively kills cancer cells expressing CD30, shows promise in treating testicular germ cell tumors (TGCTs), particularly in patients with advanced disease who have limited treatment options.
The study found that brentuximab vedotin works well in combination with certain chemotherapy drugs like etoposide and paclitaxel, but not with cisplatin, which may limit its use in standard treatment regimens for TGCTs.
The potential of brentuximab vedotin, alone or in combination with current clinical therapies, in the treatment of testicular germ cell tumors.Yeste-Velasco, M., Guo, T., Mao, X., et al.[2020]

References

A new immunotherapy strategy targeted CD30 in peripheral T-cell lymphomas: CAR-modified T-cell therapy based on CD30 mAb. [2022]
Prognostic implications of CD30 expression in extranodal natural killer/T-cell lymphoma according to treatment modalities. [2022]
The potential of brentuximab vedotin, alone or in combination with current clinical therapies, in the treatment of testicular germ cell tumors. [2020]
CD30 and its ligand: possible role in regulation of teratoma stem cells. [2019]
CD30-Redirected Chimeric Antigen Receptor T Cells Target CD30+ and CD30- Embryonal Carcinoma via Antigen-Dependent and Fas/FasL Interactions. [2020]
Toxicity and management in CAR T-cell therapy. [2023]
Preferential expansion of CD8+ CD19-CAR T cells postinfusion and the role of disease burden on outcome in pediatric B-ALL. [2022]
Shared target antigens on cancer cells and tissue stem cells: go or no-go for CAR T cells? [2017]
Seatbelts in CAR therapy: How Safe Are CARS? [2022]
Gene-modified T-cell therapy using chimeric antigen receptors for pediatric hematologic malignancies. [2017]
11.United Statespubmed.ncbi.nlm.nih.gov
CD30 antigen in embryonal carcinoma and embryogenesis and release of the soluble molecule. [2022]
CD30 as a therapeutic target in adult haematological malignancies: Where are we now? [2023]